A Pilot Study Examining the Effectiveness of Partner-Assisted Cognitive Behavioral Therapy for Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Sleep Functioning from Baseline to the End of Treatment
研究概览
简要总结
We will undertake initial development of a new behavioral sleep intervention (i.e., partner-assisted Cognitive Behavioral Therapy for Insomnia; CBT-I), based closely on the gold standard treatment, CBT-I. We will examine if the new treatment has a positive impact on subjective and objective sleep and quality of life in a clinic-based sample. Secondary aims will examine treatment adherence and maintenance of therapeutic gains as well as relationship satisfaction and broader psychiatric functioning.
详细描述
Objective: To investigate whether partner-assisted Cognitive Behavioral Therapy for Insomnia (CBT-I) has a positive impact on subjective and objective sleep and quality of life in individuals with insomnia. Secondary aims will examine treatment adherence and maintenance of therapeutic gains as well as relationship satisfaction and impact on broader psychiatric functioning.
Research Design: This is an open trial, feasibility study designed to examine the effectiveness of partner-assisted CBT-I on insomnia patient's sleep and quality of life. After individuals, Veterans and non-Veterans, and their respective bed partners consent to participate in this treatment study, we will collect de-identified data including self-report questionnaires, daily sleep diaries, and actigraphy (ambulatory sleep/wake monitoring). For Veteran participants, we also plan to collect data from medical records. Study participants will be seen for study partner-assisted CBT-I treatment at the VA San Diego Healthcare System (VASDHS) Sleep and Mood Clinic. The initial screening appointment and 1-month follow up assessment will be conducted in the Veterans Medical Research Foundation (VMRF) building. The entire study will take two years; participation for Veterans and non-Veterans will last about 3 months from the date of initial screening appointment to their follow up assessment.
Methodology:
Procedures:
Participants will primarily be recruited through the VASDHS's Sleep and Mood Clinic by physician and clinician referrals as well as posted study fliers in these clinics. Non-veterans such as those enrolled in other UCSD research studies will also be recruited. All individuals who meet eligibility criteria will be offered the opportunity to participate and informed consent will be obtained for those who wish to do so. Participation or non-participation in the protocol will not affect clinical care. Assessments of sleep symptoms, health-related quality of life, treatment adherence, relationship satisfaction, and psychiatric functioning will occur as part of standard treatment protocols. Assessments include self-report questionnaires as well as weekly sleep diaries and two weeks of actigraphy (e.g., at the start and end of treatment). Assessment data will be de-identified and analyzed to determine: (a) descriptive characteristics of study participants; (b) effectiveness of partner-assisted CBT-I treatment; (c) relationship functioning; (d) treatment adherence (e.g., did participants follow treatment recommendations from week to week); and, (e) any reduction in symptoms of psychiatric conditions that frequently co-occur with insomnia including mood and/or PTSD symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Meet diagnostic criteria for insomnia, including a score of 8 or higher on the Insomnia Severity Index (ISI)
- •Stable bed partner (i.e., someone with whom they have lived for at least one month prior to the screening appointment and someone who they anticipate to continue living with for the next two months while in the study treatment) who can commit to participating in patient's insomnia treatment. Patients and bed partners who sleep in different beds are eligible to participate.
- •English literacy
- •Participation in the group Partner-Assisted Cognitive Behavioral Therapy for Insomnia (CBT-I) class
排除标准
- •A score of 7 or lower on the Insomnia Severity Index (ISI)
- •Unmanaged psychosis or manic episodes in the past two months. For any interested potential participants with a history of bipolar disorder, their bipolar disorder must be stable (i.e., euthymic) for two months in order to be eligible to participate.
- •Diagnosed (previously or by our study screen) and untreated sleep disorder other than insomnia. Sleep disorders diagnosed, but stably treated (e.g., obstructive sleep apnea treated with CPAP) will be allowed, as long as the treatment is not a hypnotic medication.
- •Severe medical or psychiatric illness that would make it difficult to regularly attend psychotherapy sessions or participate fully in the study
- •Current substance use disorder, or meeting criteria for a SUD within the last 90 days
结局指标
主要结局
Change in Sleep Functioning from Baseline to the End of Treatment
时间窗: baseline; treatment week 4; week 8 (at end of treatment); 1 month post-treatment follow-up
Primary outcome measures (see below for more information about the measures) will assess the change in sleep functioning from baseline to the end of treatment. We will also examine change in sleep functioning from baseline to the 1-month post treatment assessment. Sleep diaries. Participants will be asked to complete a daily sleep diary throughout the 8 week treatment and one week prior to the 1 month post-treatment follow up appointment. Each morning participants are asked to record sleep habits, such as bedtime, wake time, time in bed, and number and duration of awakenings. Our sleep diary will include questions to track treatment adherence. Sleep diaries are widely used in studies of insomnia. Questionnaire. Insomnia Severity Index (ISI; Morin et al., 2011). The ISI consists of 7-items that assess severity of insomnia, satisfaction with sleep pattern, effect of sleep on daytime and social functioning, and concern about current sleep difficulties in the past week.
次要结局
- Change in Relationship Functioning from Baseline to the End of Treatment(baseline; treatment week 4; week 8 (at end of treatment); 1 month post-treatment follow-up)
- Change in Quality of Life from Baseline to the End of Treatment(baseline; treatment week 4; week 8 (at end of treatment); 1 month post-treatment follow-up)
研究者
Sean P.A. Drummond
Associate Professor of Psychiatry
University of California, San Diego